Fluid dispensing device

ABSTRACT

A fluid dispensing device for dispensing a fluid product having a dispensing outlet from which the fluid product is dispensable, a supply of the fluid product, a dispensing member mounted for movement in a dispensing direction along an axis X-X from a first position to a second position which causes a dose of the fluid product in the supply to be dispensed from the dispensing outlet and a finger-operable actuator member mounted for movement in an actuating direction which is generally transverse to the axis.

FIELD OF THE INVENTION

The present invention relates to a fluid dispensing device fordispensing a fluid product, for instance a medicament, and isparticularly, but not exclusively, concerned with an intra-nasaldispensing device.

BACKGROUND OF THE INVENTION

It is well known to provide a fluid dispenser in which fluid isdispensed via a nozzle or orifice upon the application of a force by auser to a pump dispenser. Such devices are generally arranged with areservoir containing several doses of a fluid formulation to bedispensed by sequential metered pump actuations. An example of a pumpaction spray is shown and described in U.S. Pat. No. 4,946,069.

A hand-held, manually-operable intra-nasal fluid medicament dispenser isdisclosed in WO-A-03/095007, the entire content of which is herebyincorporated herein by reference. The dispenser has a housing whichhouses a fluid discharge device having a compression pump mounted on acontainer which contains the medicament. The housing has at least onefinger-operable side lever which is movable inwardly with respect to thehousing to cam the container upwardly in the housing to cause the pumpto compress and pump a dose of the medicament out of a pump sternthrough a nasal nozzle of the housing. In an embodiment shown in FIGS.19, 19 a and 19 b, a pair of opposed side levers co-operate with acollar mounted on the neck of the container. The collar provides camfollower surfaces which ride over cam surfaces of the levers when thelevers are moved inwardly. The cam follower surfaces comprise sectionswhich are inclined at different angles to the direction (axis) of cammovement of the fluid discharge device. The steeper sections provide thedispenser with a commitment feature. In other words, only uponapplication of at least a minimum finger force to the side levers willthe levers be able to overcome the steeper cam follower surfacesections. The magnitude of this force, coupled with the change of angleof the cam follower surfaces to the shallower sections, ensures thateach lever slides rapidly over the cam follower surfaces once thesteeper cam follower surface sections are overcome thereby providing forreliable compression of the compression pump and atomisation of themedicament.

The aim of the present invention is to provide improvements to fluiddispensing devices, in particular those for intra-nasal use and/or thoseoperated with side-actuators.

SUMMARY OF THE INVENTION

According to the present invention there is provided a fluid dispensingdevice according to claim 1 hereof, a fluid dispensing device accordingto claim 30 hereof, a fluid dispensing device according to claim 37hereof, a fluid dispenser according to claim 42 hereof, a set accordingto claim 48 hereof, and a fluid dispenser according to claim 52 hereof.

Useful features of the invention are set forth in the other claimshereof.

The term “finger-operable” means operable by action of the finger orthumb, or combinations thereof, of a typical user (e.g. an adult orchild patient).

Typically, the minimum actuating force is in the range from 5 to 30N,more typically from 10 to 25N. Such values tend to correspond to a forcewhich presents a suitable ‘barrier force’ to a weak, nondescript orunintended finger movement whilst readily being overcome by thedetermined finger (or thumb) action of a user. It will be appreciatedthat if the device is designed for use by a child or elderly patient itmay have a lower minimum actuating force than that designed for adultusage.

Ideally, particularly for medicinal use, the dispenser of the inventiondispenses metered doses of the fluid product.

Ideally, the dispenser is configured and arranged to dispense each doseof the fluid product as an atomised spray.

Suitably, the fluid dispenser of the invention incorporates a pump topump the fluid product dose from the dispenser. The pump may comprise apre-compression pump, such as the VP3 or VP7 model, or a modifiedversion thereof, manufactured by Valois SA. Typically, suchpre-compression pumps are typically used with a bottle (glass orplastic) container capable of holding 8-50 ml of a fluid product. Eachactuation will typically deliver 25-150 μl, particularly 50-100 μl, ofthe fluid product (i.e. a metered dose) and the device is thereforetypically capable of providing at least 50 (e.g. 60 or 100) metereddoses.

Other suitable dispensing containers include those sold by ErichPfeiffer GmbH, Rexam-Sofab and Saint-Cobain Calmar GmbH.

For the avoidance of doubt, the various aspects of the invention can bemodified to incorporate the other aspects or one or more features of theother aspects.

Further aspects and features of the invention are set forth in thefollowing description of an exemplary embodiment of the invention madewith reference to the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side view of a fluid dispensing device of the invention.

FIG. 2 is a longitudinal sectional view of the dispenser.

FIG. 3 is a partial longitudinal sectional view of the dispenser.

FIG. 4 is an enlarged view of area A in FIG. 3.

FIG. 5 is an enlarged view of area B in FIG. 3.

FIG. 6 is a fragmentary, enlarged underneath plan view of a nozzle ofthe fluid dispensing device mounted in a housing of the device.

FIG. 7A is a schematic plan view of an actuator lever of the fluiddispensing device.

FIG. 7B is a side view of the lever taken on arrow A in FIG. 7A.

FIG. 8 is a side view of the nozzle.

FIG. 9 is a schematic representation of a guide mechanism of the fluiddispensing device.

FIG. 10 is an enlarged view of one of a pair of beaks of the lever whichpresent a cam profile.

FIG. 11 is a fragmentary, schematic view of the lever in an outwardposition relative to the housing of the fluid dispensing device.

DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENT OF THE INVENTION

FIGS. 1 to 11 show a fluid dispensing device 1405 for spraying a fluidinto a nasal cavity of a human user which is in accordance with thepresent invention.

The fluid dispensing device 1405 comprises a plastics housing 1409 (e.g.of ABS), a nozzle 1411 for insertion into the nasal cavity at an upperend of the housing 1409 and a fluid discharge device 1408 housed withinthe housing 1409 for reciprocal translation along its longitudinal axisX-X. As shown in FIGS. 1 to 5, when the fluid discharge device 1408 isreceived in the housing 1409, its longitudinal axis X-X is in-line withthe nozzle 1411.

The outer surface, or a part of the outer surface, of the nozzle 1411can be made from a soft-touch plastics material. However, in thisembodiment the nozzle 1411 is made from polypropylene (PP).

The fluid discharge device 1408 comprises a container 1430, for storingenough of the fluid for multiple metered doses thereof to be dispensed,and a compression pump 1429 mounted on the container 1430. The container1430 is made from a translucent or transparent plastics material,although it will be apparent that it could be made from othertranslucent or transparent materials, such as glass. The pump 1429 has asuction inlet 1461, in the form of a dip tube, located within thecontainer 1430 and a discharge outlet 1463, in the form of a pump stem,for transferring fluid from the pump 1429 to the nozzle 1411.

The housing 1409 is provided with a window 1450 through which the levelof the fluid in the container 1430 can be checked.

Pivotally mounted to the housing is a finger operable means 1420 toapply a force to the container 1430 in a direction which is transverseto the longitudinal axis X-X. This transverse force moves the container1430 towards the nozzle 1411 along the longitudinal axis X-X so as toactuate the pump 1429. The finger operable means is in the form of alever 1420 (e.g. of ABS) pivotally connected at its lower end to thehousing 1409 and arranged to act upon the container 1430 so as to urgethe container 1430 towards the nozzle 1411 when the lever 1420 ispivoted inwardly by a user's finger or thumb.

A protective end cap 1407 is provided for protection of the nozzle 1411.First and second lugs 1449 a, 1449 b project from the protective end cap1407 for receipt within suitably arranged channels 1451 a, 1451 bprovided within the housing 1409 such as to allow secure attachment ofthe end cap 1407 to the housing 1409. When so-received, first lug 1449 afurther interferes with movement of lever 1420 such as to preventactuation (i.e. to lock movement) of the lever 1420 when the end cap1407 and lugs 1449 a, 1449 b are in place (i.e. in the nozzle coveredposition).

The end cap 1407 also has a protruding stopper 1460 which has a convex,resilient end form 1461 arranged for sealing engagement with thedispensing orifice 1415 of the nozzle 1411 so as provide an essentiallyairtight seal to nozzle orifice 1415 to prevent fluid drain back whenthe stopper 1460 is in place.

The end cap is suitably made from the same material as the housing, e.g.a plastics material, suitably ABS.

As will be understood by reference to FIGS. 3, 5 and 7A, the lever 1420has a pair of beaks or noses 1421 which each present a cam surface 1422arranged for interaction with one of a pair of cam follower surfaces1492 provided on a collar 1490 (e.g. of acetal) fixed around the neck ofthe container 1430. It will be appreciated that a sideways force (i.e.substantially transversely to the longitudinal axis X-X of the fluiddischarge device 1408) applied to the lever 1420 results in the camfollower surfaces 1492 riding over the cam surfaces 1422 therebyresulting in upward movement (i.e. along the longitudinal axis X-X) ofthe fluid discharge device 1408.

In more detail, the beaks 1421 are located at the upper end of the lever1420 on opposite sides thereof. In plan view, the upper end of the lever1420 has a U-shaped cross section, as shown in FIG. 7A. The beaks 1421straddle opposed sides of the fluid discharge device 1408 forco-operation with the diametrically opposed cam follower surfaces 1492on the collar 1490. Noting that the fluid dispensing device 1405 onlyhas one actuator lever 1420, the use of a pair of beaks 1421 improvesthe ability of the lever 1420 to cam the fluid discharge device 1408upwardly along its longitudinal axis X-X.

Each cam surface 1422 of the lever 1420 has a variable mechanical ratioarranged such that until a pre-determined force is applied to the lever1420 no significant force is transferred to the container 1430. In moredetail, each cam surface 1422 has a commitment portion 1423 a which isinclined at a first angle to the longitudinal axis X-X of the fluiddischarge device 1408 and a drive portion 1423 b inclined to thelongitudinal axis X-X second angle which is greater than the firstangle. The first angle should be no less than approximately 20°, and issuitably in the range of approximately 20-35°, more suitably approx.20-26°, even more suitably approx. 22-26°. The second angle may be inthe range of approximately 40-60°, suitably approx. 40-50°, moresuitably approx. 45°.

Therefore, when an inward force is initially applied to the lever 1420it is applied substantially normally to the longitudinal axis X-X of thefluid discharge device 1408 and virtually no force is converted into aforce along the longitudinal axis X-X of the fluid discharge device 1408and so the static friction between the commitment portions 1423 a of thebeaks 1421 and the cam follower surfaces 1492 is sufficient to maintainthe lever 1420 effectively stationary. However, when a pre-determinedload is applied to the lever 1420 the static friction is overcome andthe cam follower surfaces 1492 start riding on the commitment portions1423 a.

When the cam follower surfaces 1492 reach the end of the commitmentportions 1423 a, the increase in inclination of the cam surfaces to thelongitudinal axis X-X in combination with the magnitude of the forcebeing applied ensures that the cam follower surfaces 1490 suddenly sliderapidly along the drive portions 1423 b causing the container 1430 to bemoved rapidly towards the nozzle 1411 to actuate the compression pump.This ensures that the pump is only actuated when sufficient force isbeing applied to guarantee the production of an effective spray from thenozzle 1411.

Referring to FIG. 10, it will be seen that the commitment portions 1423a are planar sections of the cam surfaces 1422, whereas the driveportions 1423 b are arcuate. More specifically, the drive portions 1423b have a short rounded transition section 1423 c contiguous with theassociated commitment portion 1423 a. The transition sections 1423 chave a radius of curvature R1 which is greater than the radius ofcurvature R2 of the remainder of the drive portion 1423 b, which radiusR2 is constant over the length of the remainder of the drive portion1423 b. The transition portions 1423 c smooth the transfer of the camfollower surfaces 1429 from the commitment portions 1423 a of the camsurfaces 1422 to the drive portions 1423 b. They also reduce wearing ofthe cam surfaces 1422.

R1 in this embodiment is about 3 mm, while R2 is about 25 mm.Nonetheless, other radii could be used, as will be appreciated by theskilled person in the art.

Referring to FIG. 3, the cam follower surfaces 1492 are rounded edges ofdiametrically-opposed embossments 1493 on the plastic collar 1490. Thismakes riding of the cam follower surfaces 1492 on the cam surfaces 1422easier, and also reduces wearing of the respective surfaces.

As shown in FIGS. 5 and 10, the beaks 1421 have a tip which forms acradle 1424 for the embossments 1493 on the collar 1490 of the fluiddischarge device 1408 to rest on. The cradles 1424 present a supportsurface 1424 a which extends transversely to the longitudinal axis X-Xon which the embossments 1493 can be supported. The cradles 1424 act asa back-stop for the fluid discharge device 1408 insofar as preventingthe fluid discharge device 1408 moving downwardly beyond the point atwhich the cradles 1424 engage with the embossments 1493. As will be seenfrom FIG. 5, this ensures that the cam follower surfaces 1492 arealigned with the commitment portion 1423 a of the cam surfaces 1422.

Noting that the lever 1420 pivots inwardly, it will be appreciated thatas the lever 1420 pivots inwardly the inclined angle which the planarcommitment portions 1423 a make with the longitudinal axis X-X becomessmaller (steeper) thereby increasing the resistance of the fluiddischarge device 1408 to being cammed upwardly.

However, the arcuate nature of the drive portions 1423 b, in particularthat part after the transition section 1423 c, is such that the inclinedangle it makes with the longitudinal axis X-X remains the same, orsubstantially the same, as the lever 1420 pivots inwardly. Morespecifically, consider that as the lever 1420 pivots inwardly the pointon the section of the drive portion 1423 b having the radius ofcurvature R2 which is in contact with the cam follower surface 1492moves up the cam surface 1422. The angle that a tangent to this changingcontact point makes with the longitudinal axis X-X remains the same, orsubstantially the same, as the lever 1420 pivots inwardly to cause thefluid discharge device 1408 to spray a metered dose of the fluid productfrom the nozzle 1411. This feature means that the resistance to theinward movement of the lever 1420 never increases after the commitmentfeature has been overcome, as would be the case if the drive portion1423 b were a planar surface since its angle to the longitudinal axisX-X would then increase as the lever 1420 pivots inwardly.

The aforementioned features of the cam profile mean that the operatorreceives smooth tactile feedback from the device 1405 when the lever1420 is actuated to cause the fluid discharge device 1408 to spray ametered dose of the fluid product from the nozzle 1411.

To use the fluid dispensing device 1405 a user first has to remove theprotective cap 1407 thereby unsealing the nozzle orifice 1415 byremoving the stopper end 1460 therefrom. The user then grasps the fluiddispensing device 1405 and places a thumb and/or finger on the lever1420.

Provided that only a light pressure is applied to the lever 1420 nofluid will be discharged and the user is able to manoeuvre thedispensing nozzle 1411 of the fluid dispensing device 1405 into one oftheir nostrils so that the fluid is able to be dispensed into the nasalcavity.

If the user then squeezes the lever 1420 inwards with increasing forcethe threshold force defined by the interaction of the cam followersurfaces 1492 with the commitment portions 1423 a of the cam surfaces1422 is overcome resulting in the container 1430 being moved rapidlytowards the nozzle 1411 to actuate the pump 1429 and dispense fluid tothe dispensing orifice 1415. Upon release of the pressure applied to thelever 1420 the pump is reset by its internal return spring. Moreover,the lever 1420 has a leaf spring 1465 (FIG. 2) which acts against ahousing inner wall 1467 to bias the lever 1420 to its rest positionshown in FIGS. 1 to 3 and 5.

The actuating procedure can then be repeated until all of the fluid inthe container 1430 has been used. However, only one or two doses offluid are normally administered at a time.

Referring to FIGS. 5 and 9, to counteract the lateral force which thelever 1420 applies to the fluid discharge device 1408, and to guide theaxial displacement of the fluid discharge device 1408 in response to thelever operation, the collar 1490 has a pair of diametrically opposed,tracks 1469 which are arranged parallel to the longitudinal axis X-X.These tracks 1469 are provided by the embossments 1493. Each track 1469has a funnel shape at its upper end for self-guiding of the tracks 1469onto complementary axially-extending runners 1467, presented on theinner surface of the housing 1409, when the fluid discharge device 1408is inserted into the housing 1409 through an (lower) opening 1471 in itslower end, which lower opening 1471 is subsequently closed with a cap1472. It will also be appreciated that the track-runner mechanismpositions the collar 1490 in the correct angular orientation about thelongitudinal axis X-X so that the cam follower surfaces 1492 face thecam surfaces 1422.

In use, the tracks 1469 ride on the runners 1467 when the lever 1420overcomes the threshold force provided by the commitment portions 1423 aof the cam surfaces 1422. As will be appreciated, the co-operation ofthe tracks 1469 with the runners 1467 prevents rotation of the collar1490 in the housing 1409.

In addition to the tracks 1469, the collar also has a sheath 1473 forthe pump stem 1463 which forms a sliding fit on an inner hollow post1475 of the nozzle 1411 in which a nozzle outlet passage 1477 is formed.As shown in FIG. 2, the pump stem 1463 is located in a lower widenedportion of the outlet passageway 1477 through an interference fit. Itwill therefore be appreciated that the pump stem 1463 remains stationaryin the housing 1409 as the container 1430 and the collar 1490 aretranslated upwardly by the lever 1420, i.e. there is relative movementbetween the container-collar unit and the pump stem. In this way, thepump 1429 is compressed and a metered dose of the fluid productdischarged through the pump stem 1463 into the outlet passageway 1477for ejection from the nozzle orifice 1415 at the end of the outletpassageway 1477. The commitment feature on the lever 1420 ensures thatthe pumping force is sufficient for atomisation of the fluid productfrom the nozzle 1411.

As shown in FIG. 8, the nozzle 1411 in this embodiment is formed as aseparate part from the housing 1409. This has advantages when the fluidproduct being dispensed is a medicament because this isolates the onlypart of the device that comes into contact with the medicament.Accordingly, testing of the pharmaceutical performance of the nozzle1411 can be conducted without the need for the housing 1409. So, oncethe nozzle 1411 is complete, testing of it can begin while thedevelopment and design of the housing 1409 continues. Therefore there isno hold up in the device development, as would be the case if the nozzle1411 were integrally formed with the housing 1409. Any change in themoulding of the housing would require re-testing of the nozzle 1411 toconfirm that the new moulding has had no adverse effect on the nozzleperformance.

In addition, having a separate nozzle 1411 means that the housing 1409can be customised for different markets and/or different products. As anexample, the nozzle 1411 could be a universal nozzle for a set ofhousings having different shapes, different colours, etc.

A further advantage of a separate nozzle 1411 is that it can be moreeasily formed from a different material than the housing 1409, forexample one that is more acceptable for insertion into a nostril and/orfor contacting the fluid product, especially where this is a medicament,but which might be too expensive to form the whole housing 1409 from.

To this end, and as shown in FIG. 2, the housing 1409 has an (upper)opening 1480 at its upper end through which the nozzle 1411 isinsertable. Referring to FIGS. 2, 6 and 8, the nozzle 1411 has a flange1481 at its lower end which engages the inner mouth of the upper opening1480 so that the tip of the nozzle 1411 projects from the upper opening1480 the required distance for nasal use. As will be seen from FIGS. 2and 6, the inner mouth of the upper opening 1480 is bounded by a collar1483 formed from a series of collar segments 1485 angularly spaced-apartabout the longitudinal axis X-X. The collar segments 1485 are bent overthe nozzle flange 1481 by a swaging tool to clamp the nozzle flange 1481against the inner mouth to fix the nozzle 1411 in the upper opening1480.

To assist in assembly of the fluid dispensing device 1405, the lever1420 is provided with means to enable it to be disposed in an outwardposition with respect to the housing 1409, to allow the fluid dischargedevice 1408 to be inserted into the housing 1409 through the loweropening 1471 to its rest position shown in FIGS. 1, 3 and 5, and theinward position with respect to the housing 1409 shown in FIGS. 1 to 3.

Referring to FIGS. 7A, 7B and 11, at the upper end of the lever 1420there is provided a tab 1501 which projects above the upper edge 1502 ofthe lever 1420. The tab 1501 projects from a resilient bridge element1503 formed by a cut-out 1505 in the lever 1420. The resilient bridgeelement 1503 biases the tab 1501 to its extended position shown in FIGS.7A, 7B and 11, but enables the tab 1501 to be depressed so that it isflush with, or below, the lever upper edge 1502.

As will be understood from FIG. 1, the lever 1420 is mounted in a slot1507 formed in the side of the housing 1409. The lever 1420, which isformed separately from the housing 1409, but from the same plasticsmaterial, is mounted to the housing by first inserting its lower end1509, which carries the leaf spring 1465, through the slot 1507 to bereceived in an axial channel 1511. The lever 1420 is now disposed in itsoutward position with the tab 1501 bearing against the edge of the slot1507 to prevent the lever 1420 being moved through the slot 1507 to itsinward position, as schematically shown in FIG. 11.

When the lever 1420 is in its outward position, the fluid dischargedevice 1408 is able to be inserted into the housing 1409 through thelower housing opening 1471 to its rest position because the lever 1420,and its beaks 1422 in particular, do not impede the loading of the fluiddischarge device 1408.

After the fluid discharge device 1408 has been loaded to its restposition, the lever 1420 is moved to its inward position by depressingthe tab 1501 so that it clears the edge of the slot 1507 and thenpushing the lever 1420 inwardly to its position shown in FIG. 2, forexample. If the lever 1420 were in its inward position before the fluiddischarge device 1408 were loaded into the housing 1409, the fluiddischarge device could not be loaded into the housing 1409 to its restposition, not without damaging the lever 1420 in any event.

As shown in FIG. 2, for example, once the lever 1420 is moved to itsinward position, the tab 1501 returns to its extended position and bearsagainst an inner surface of the housing 1409 to maintain the lever 1420in the inward position. In this regard, the lever leaf spring 1465biases the lever 1420 outwardly.

In more detail, the tab 1501 bears against an inner surface of one ofthe channels 1451 a in the housing 1409 in which the cap lugs 1449 a,1449 b are snap-fitted to hold the protective cap 1407 releasablycaptive on the housing 1409. As shown in FIG. 2, the lug 1449 a receivedin the channel 1451 a is located in front of the tab 1501. It willtherefore be gathered that the lever 1420 is prevented from movinginwardly when the cap 1407 is in place, to actuate the fluid dispensingdevice 1405, by the lug 1449 a blocking inward movement of the lever tab1501.

Those parts of the fluid dispensing device 1405 made from a plasticsmaterial are formed by a moulding process.

Other features of this exemplary embodiment are contained in the othersections of this specification, including, without limitation, theappended claims and statements in the ‘Summary of the Invention’ sectionsupra.

The fluid discharge device 1408 may contain a medicament formulation,for example for the treatment of mild, moderate or severe acute orchronic symptoms or for prophylactic treatment. The precise doseadministered will depend on the age and condition of the patient, theparticular medicament used and the frequency of administration and willultimately be at the discretion of the attendant physician. Whencombinations of medicaments are employed the dose of each component ofthe combination will in general be that employed for each component whenused alone.

Appropriate medicaments may be selected from, for example, analgesics,e.g., codeine, dihydromorphine, ergotamine, fentanyl or morphine;anginal preparations, e.g., diltiazem; antiallergics, e.g., cromoglycate(eg as the sodium salt), ketotifen or nedocromil (eg as the sodiumsalt); antiinfectives e.g., cephalosporins, penicillins, streptomycin,sulphonamides, tetracyclines and pentamidine; antihistamines, e.g.,methapyrilene; anti-inflammatories, e.g., beclomethasone (eg as thedipropionate ester), fluticasone (eg as the propionate ester),flunisolide, budesonide, rofleponide, mometasone (eg as the furoateester), ciclesonide, triamcinolone (eg as the acetonide),6α,9α-difluoro-11β-hydroxy-16α-methyl-3-oxo-17α-propionyloxy-androsta-1,4-diene-17β-carbothioicacid S-(2-oxo-tetrahydro-furan-3-yl) ester or6α,9α-Difluoro-17α-[(2-furanylcarbonyl)oxy]-11β-hydroxy-16α-methyl-3-oxo-androsta-1,4-diene-17β-carbothioicacid S-fluoromethyl ester; antitussives, e.g., noscapine;bronchodilators, e.g., albuterol (eg as free base or sulphate),salmeterol (eg as xinafoate), ephedrine, adrenaline, fenoterol (eg ashydrobromide), formoterol (eg as fumarate), isoprenaline,metaproterenol, phenylephrine, phenylpropanolamine, pirbuterol (eg asacetate), reproterol (eg as hydrochloride), rimiterol, terbutaline (egas sulphate), isoetharine, tulobuterol or4-hydroxy-7-[2-[[2-[[3-(2-phenylethoxy)propyl]sulfonyl]ethyl]amino]ethyl-2(3H)-benzothiazolone;PDE4 inhibitors eg cilomilast or roflumilast; leukotriene antagonists egmontelukast, pranlukast and zafirlukast; [adenosine 2a agonists, eg2R,3R,4S,5R)-2-[6-Amino-2-(1S-hydroxymethyl-2-phenyI-ethylamino)-purin-9-yl]-5-(2-ethyl-2H-tetrazol-5-yl)-tetrahydro-furan-3,4-diol(e.g. as maleate)]*; [α4 integrin inhibitors eg(2S)-3-[4-({[4-(aminocarbonyl)-1-piperidinyl]carbonyl}oxy)phenyl]-2-[((2S)-4-methyl-2-{[2-(2-methylphenoxy)acetyl]amino}pentanoyl)amino]propanoicacid (e.g as free acid or potassium salt)]*, diuretics, e.g., amiloride;anticholinergics, e.g., ipratropium (eg as bromide), tiotropium,atropine or oxitropium; hormones, e.g., cortisone, hydrocortisone orprednisolone; xanthines, e.g., aminophylline, choline theophyllinate,lysine theophyllinate or theophylline; therapeutic proteins andpeptides, e.g., insulin or glucagons. It will be clear to a personskilled in the art that, where appropriate, the medicaments may be usedin the form of salts, (e.g., as alkali metal or amine salts or as acidaddition salts) or as esters (e.g., lower alkyl esters) or as solvates(e.g., hydrates) to optimise the activity and/or stability of themedicament and/or to minimise the solubility of the medicament in thepropellant.

Preferably, the medicament is an anti-inflammatory compound for thetreatment of inflammatory disorders or diseases such as asthma andrhinitis.

In one aspect, the medicament is a glucocorticoid compound, which hasanti-inflammatory properties. One suitable glucocorticoid compound hasthe chemical name:6α,9α-Difluoro-17α-(1-oxopropoxy)-11β-hydroxy-16α-methyl-3-oxo-androsta-1,4-diene-17β-carbothioicacid S-fluoromethyl ester (fluticasone propionate). Another suitableglucocorticoid compound has the chemical name:6α,9α-difluoro-17α-[(2-furanylcarbonyl)oxy]-11β-hydroxy-16α-methyl-3-oxo-androsta-1,4-diene-17β-carbothioicacid S-fluoromethyl ester. A further suitable glucocorticoid compoundhas the chemical name:6α,9α-Difluoro-11β-hydroxy-16α-methyl-17α-[(4-methyl-1,3-thiazole-5-carbonyl)oxy]-3-oxo-androsta-1,4-diene-17β-carbothioicacid S-fluoromethyl ester.

Other suitable anti-inflammatory compounds include NSAIDs e.g. PDE4inhibitors, leukotriene antagonists, iNOS inhibitors, tryptase andelastase inhibitors, beta-2 integrin antagonists and adenosine 2aagonists.

The medicament is formulated as any suitable fluid formulation,particularly a solution (e.g. aqueous) formulation or a suspensionformulation, optionally containing other pharmaceutically acceptableadditive components.

Suitably, the fluid medicament formulation herein has a viscosity offrom 10 to 2000 mpa.s (10 to 2000 centipoise), particularly from 20 to1000 mpa.s (20 to 1000 centipoise), such as from 50 to 1000 mpa.s (50 to1000 centipoise) at 25° C.

Suitable formulations (e.g. solution or suspension) may be stabilised(e.g. using hydrochloric acid or sodium hydroxide) by appropriateselection of pH. Typically, the pH will be adjusted to between 4.5 and7.5, preferably between 5.0 and 7.0, especially around 6 to 6.5.

Suitable formulations (e.g. solution or suspension) may comprise one ormore excipients. By the term “excipient”, herein, is meant substantiallyinert materials that are non-toxic and do not interact with othercomponents of a composition in a deleterious manner including, but notlimited to, pharmaceutical grades of carbohydrates, organic andinorganic salts, polymers, amino acids, phospholipids, wetting agents,emulsifiers, surfactants, poloxamers, pluronics, and ion exchangeresins, and combinations thereof.

Suitable carbohydrates include monosaccharides include fructose;disaccharides, such as, but not limited to lactose, and combinations andderivatives thereof; polysaccharides, such as, but not limited to,cellulose and combinations and derivatives thereof; oligosaccharides,such as, but not limited to, dextrins, and combinations and derivativesthereof; polyols, such as but not limited to sorbitol, and combinationsand derivatives thereof.

Suitable organic and inorganic salts include sodium or calciumphosphates, magnesium stearate, and combinations and derivativesthereof.

Suitable polymers include natural biodegradable protein polymers,including, but not limited to, gelatin and combinations and derivativesthereof; natural biodegradable polysaccharide polymers, including, butnot limited to, chitin and starch, crosslinked starch and combinationsand derivatives thereof; semi-synthetic biodegradable polymers,including, but not limited to, derivatives of chitosan; and syntheticbiodegradable polymers, including, but not limited to, polyethyleneglycols (PEG), polylactic acid (PLA), synthetic polymers including butnot limited to polyvinyl alcohol and combinations and derivativesthereof;

Suitable amino acids include non-polar amino acids, such as leucine andcombinations and derivatives thereof. Suitable phospholipids includelecithins and combinations and derivatives thereof.

Suitable wetting agents, surfactants and/or emulsifiers include gumacacia, cholesterol, fatty acids including combinations and derivativesthereof. Suitable poloxamers and/or Pluronics include poloxamer 188,Pluronic® F-108, and combinations and derivations thereof. Suitable ionexchange resins include amberlite IR120 and combinations and derivativesthereof;

Suitable solution formulations may comprise a solubilising agent such asa surfactant. Suitable surfactants includeα-[4-(1,1,3,3-tetramethylbutyl)phenyl]-ω-hydroxypoly(oxy-1,2-ethanediyl)polymers including those of the Triton series e.g. Triton X-100, TritonX-114 and Triton X-305 in which the X number is broadly indicative ofthe average number of ethoxy repeating units in the polymer (typicallyaround 7-70, particularly around 7-30 especially around 7-10) and4-(1,1,3,3-tetramethylbutyl)phenol polymers with formaldehyde andoxirane such as those having a relative molecular weight of 3500-5000especially 4000-4700, particularly Tyloxapol. The surfactant istypically employed in a concentration of around 0.5-10%, preferablyaround 2-5% w/w based on weight of formulation.

Suitable solution formulations may also comprise hydroxyl containingorganic co-solvating agents include glycols such as polyethylene glycols(eg PEG 200) and propylene glycol; sugars such as dextrose; and ethanol.Dextrose and polyethylene glycol (eg PEG 200) are preferred,particularly dextrose. Propylene glycol is preferably used in an amountof no more than 20%, especially no more than 10% and is most preferablyavoided altogether. Ethanol is preferably avoided. The hydroxylcontaining organic co-solvating agents are typically employed at aconcentration of 0.1-20% e.g. 0.5-10%, e.g. around 1-5% w/w based onweight of formulation.

Suitable solution formulations may also comprise solublising agents suchas polysorbate, glycerine, benzyl alcohol, polyoxyethylene castor oilsderivatives, polyethylene glycol and polyoxyethylene alkyl ethers (e.g.Cremophors, Brij).

Suitable solution formulations may also comprise one or more of thefollowing components: viscosity enhancing agents; preservatives; andisotonicity adjusting agents.

Suitable viscosity enhancing agents include carboxymethylcellulose,veegum, tragacanth, bentonite, hydroxypropylmethylcellulose,hydroxypropylcellulose, hydroxyethylcellulose, poloxamers (eg. poloxamer407), polyethylene glycols, alginates xanthym gums, carageenans andcarbopols.

Suitable preservatives include quaternary ammonium compounds (e.g.benzalkonium chloride, benzethonium chloride, cetrimide andcetylpyridinium chloride), mercurial agents (e.g. phenylmercuricnitrate, phenylmercuric acetate and thimerosal), alcoholic agents (e.g.chlorobutanol, phenylethyl alcohol and benzyl alcohol), antibacterialesters (e.g. esters of para-hydroxybenzoic acid), chelating agents suchas disodium edetate (EDTA) and other anti-microbial agents such aschlorhexidine, chlorocresol, sorbic acid and its salts and polymyxin.

Suitable isotonicity adjusting agents act such as to achieve isotonicitywith body fluids (e.g. fluids of the nasal cavity), resulting in reducedlevels of irritancy associated with many nasal formulations. Examples ofsuitable isotonicity adjusting agents are sodium chloride, dextrose andcalcium chloride.

Suitable suspension formulations comprise an aqueous suspension ofparticulate medicament and optionally suspending agents, preservatives,wetting agents or isotonicity adjusting agents.

The particulate medicament suitably has a mass mean diameter (MMD) ofless than 20 μm, preferably between 0.5-10 μm, especially between 1-5μm. If particle size reduction is necessary, this may be achieved bytechniques such as micronisation and/or microfluidisation.

Suitable suspending agents include carboxymethylcellulose, veegum,tragacanth, bentonite, methylcellulose and polyethylene glycols.

Suitable wetting agents function to wet the particles of medicament tofacilitate dispersion thereof in the aqueous phase of the composition.Examples of wetting agents that can be used are fatty alcohols, estersand ethers. Preferably, the wetting agent is a hydrophilic, non-ionicsurfactant, most preferably polyoxyethylene (20) sorbitan monooleate(supplied as the branded product Polysorbate 80).

Suitable preservatives and isotonicity adjusting agents are as describedabove in relation to solution formulations.

The dispensing device herein is suitable for dispensing fluid medicamentformulations for the treatment of inflammatory and/or allergicconditions of the nasal passages such as rhinitis e.g. seasonal andperennial rhinitis as well as other local inflammatory conditions suchas asthma, COPD and dermatitis.

A suitable dosing regime would be for the patient to inhale slowlythrough the nose subsequent to the nasal cavity being cleared. Duringinhalation the formulation would be applied to one nostril while theother is manually compressed. This procedure would then be repeated forthe other nostril. Typically, one or two inhalations per nostril wouldbe administered by the above procedure up to three times each day,ideally once daily. Each dose, for example, may deliver 5 μg, 50 μg, 100μg, 200 μg or 250 μg of active medicament. The precise dosage is eitherknown or readily ascertainable by those skilled in the art.

It will be understood that the present disclosure is for the purpose ofillustration only and the invention extends to modifications, variationsand improvements thereto.

All usage herein of terms such as “about”, “approximately”,“substantially” and the like in relation to a parameter or property ismeant to include the exact parameter or property as well as immaterialdeviations therefrom.

1. A fluid dispensing device for dispensing a fluid product having: adispensing outlet from which the fluid product is dispensable, a supplyof the fluid product, a dispensing member mounted for movement in adispensing direction along an axis from a first position to a secondposition which causes a dose of the fluid product in the supply to bedispensed from the dispensing outlet, and a finger-operable actuatormember mounted for movement in an actuating direction which is generallytransverse to the axis, wherein the actuator member has at least one camsurface and the dispensing member has at least one cam follower surface,wherein the actuator member is movable in the actuating direction tocause the at least one cam surface to bear against the at least one camfollower surface to force the at least one cam follower surface to rideover the cam surface to cam the dispensing member in the dispensingdirection from the first position to the second position, wherein the atleast one cam surface has a commitment section, oriented at a firstangle to the axis, and an adjacent drive section, which is oriented at asecond angle to the axis which is greater than the first angle, whereinthe device is configured and arranged such that, in use, the at leastone cam follower surface successively rides over the commitment anddrive sections of the at least one cam surface, on movement of theactuator member in the actuating direction, to cam the dispensing memberfrom the first position to the second position, and wherein the firstangle is selected such that a minimum actuating force is required to beapplied to the actuator member to cause the at least one cam followersurface to ride over the commitment section onto the drive section. 2.The device of claim 1, wherein the first angle is in the range of about20-35°.
 3. The device of claim 1, wherein the commitment section isplanar.
 4. The device of claim 1, wherein the minimum actuating force isin the range of about 20-45N.
 5. The device of claim 1, wherein thesecond angle is in the range of about 40-60°.
 6. The device of claim 1,wherein the drive section has an arcuate transition portion contiguouswith the commitment section.
 7. The device of claim 6, wherein thetransition portion has a radius of curvature in the range of about 1-5mm.
 8. The device of claim 1, wherein the drive section is arcuate. 9.The device of claim 8, wherein the drive section has a first portion ofa first radius of curvature contiguous with the commitment section and asecond portion, contiguous with the first portion, of a second radius ofcurvature which is greater than the first radius of curvature.
 10. Thedevice of claim 1, wherein the drive section consists of the first andsecond portions.
 11. The device of claim 1, wherein the commitmentsection is of a first length and the drive section is of a second lengthgreater than the first length.
 12. The device of claim 1, wherein theminimum actuating force is in the range of about 25-40N.
 13. The deviceof claim 1, wherein the at least one cam follower surface is arcuate.14. The device of claim 9, wherein the second portion has a radius ofcurvature in the range of about 15-40 mm.
 15. The device of claim 1,wherein the actuator member is mounted in the device for movement on anarcuate path in the actuating direction.
 16. The device of claim 1,configured and arranged such that the first angle to the axis becomessteeper as the actuator member moves in the actuating direction.
 17. Thedevice of claim 1, configured and arranged such that the second angle tothe axis remains constant, or substantially constant, as the actuatormember moves in the actuating direction.
 18. The device of claim 1,wherein the actuator member is mounted for pivotal movement about afirst end thereof and the at least one cam surface is disposed on theactuator member remote from the first end.
 19. The device of claim 1,wherein the dispensing member is a dispensing container in which thesupply of the fluid product is contained.
 20. The device of claim 18,wherein the dispensing direction is an upward direction and the firstend of the actuator member is a lower end thereof.
 21. The device ofclaim 20, wherein the at least one cam follower surface is disposedtowards an upper end of the dispensing member.
 22. The device of claim19, wherein the dispensing container has a pump which is caused to pumpthe dose of the fluid product from the dispensing outlet in response tothe dispensing container being moved in the dispensing direction by theactuator member.
 23. The device of claim 1, wherein the actuator memberis the sole actuator member.
 24. The device of claim 1, wherein thedispensing outlet is in a nozzle sized and shaped for insertion into abody cavity.
 25. The device of claim 24, wherein the nozzle is forinsertion into a nostril of a human or animal body.
 26. The device ofclaim 1, wherein the fluid product is a medicament.
 27. The device ofclaim 1, wherein the dispensing member and housing have co-operatingguide members for guiding movement of the dispensing member along theaxis.
 28. The device of claim 27, wherein the co-operating guide membersprevent rotation of the dispensing member about the axis.
 29. The deviceof claim 27, wherein one of the guide members comprises a runner and theother guide member comprises a track for the runner.
 30. A fluiddispensing device for dispensing a fluid product having: a dispensingoutlet from which the fluid product is dispensable, a supply of thefluid product, a dispensing member mounted for movement in a dispensingdirection along an axis which causes a dose of the fluid product in thesupply to be dispensed from the dispensing outlet, and a finger-operableactuator member mounted for movement in an actuating direction which isgenerally transverse to the axis, wherein the actuator member has atleast one cam surface and the dispensing member has at least one camfollower surface, wherein the actuator member is movable in theactuating direction to cause the at least one cam surface to bearagainst the at least one cam follower surface to cam the dispensingmember in the dispensing direction to cause the fluid product dose to bedispensed from the dispensing outlet, and wherein the actuator memberfurther has a stop to stop the dispensing member being movable along theaxis in a direction opposite the dispensing direction beyond apredetermined axial position to provide alignment of the least one camsurface and the at least one cam follower surface.
 31. The device ofclaim 30, wherein the stop comprises at least one stop surface engagablewith a respective surface of the dispensing member.
 32. The device ofclaim 31, wherein the at least one stop surface extends generallytransversely to the axis.
 33. The device of claim 31, wherein the atleast one stop surface forms a continuation of the at least one camsurface.
 34. The device of claim 31, wherein the at least one surface ofthe dispensing member forms a continuation of the at least one camfollower surface.
 35. The device of claim 30, wherein the at least onecam surface is presented by a nose section of the actuator member. 36.The device of claim 35, wherein the stop comprises at least one stopsurface engagable with a respective surface of the dispensing member andthe at least one stop surface is presented by a lip portion of the nosesection.
 37. A fluid dispensing device for dispensing a fluid producthaving: a housing with a dispensing outlet, the housing adapted toreceive therein a dispensing container containing the fluid product formovement of the dispensing container along an axis from a rest positionrelative to the housing to a dispensing position relative to the housingwhich causes the dispensing container to dispense a dose of the fluidproduct through the dispensing outlet, the housing having an accessopening through which the dispensing container is insertable into thehousing along the axis to the rest position, and at least onefinger-operable actuator member mounted in the housing for movementinwardly with respect to the housing, transverse to the axis, to causethe dispensing container to move from the rest position to thedispensing position, wherein the actuator member is movable from anoutward position with respect to the housing, which enables thedispensing container to be inserted through the access opening to therest position in the housing, to an inward position with respect to thehousing, which prevents the dispensing container being inserted throughthe access opening to the rest position in the housing, but from whichinward position the actuator member is able to be moved inwardly withrespect to the housing to cause a dispensing container disposed in therest position to move to the dispensing position, and wherein the devicehas a releasble detent mechanism for selectively holding the actuatormember in its outward and inward positions.
 38. The dispenser of claim37, wherein the detent mechanism is on the housing and/or the actuatormember.
 39. The dispenser of claim 37, wherein the detent mechanismcomprises a stop element on either the housing or the actuator memberwhich is movable from a first position, which prevents movement of theactuator member between the outward and inward positions, to a secondposition, which enables movement between the outward and inwardpositions, to a second position, which enables movement of the actuatormember between the outward and inward positions.
 40. The dispenser ofclaim 39, wherein the detent mechanism comprises a bias to bias the stopelement to its first position.
 41. The dispenser of claim 39, in whichthe stop element is on the actuator member and abuts the housing in itsfirst position.
 42. A fluid dispenser adapted for dispensing a fluidproduct into the nasal cavity of a suer having a nozzle sized and shapedfor insertion into a nostril of the user and a housing in which thefluid product is containable, wherein the housing has an opening inwhich the nozzle is received and a fastening mechanism which fastens thenozzle in the opening.
 43. The dispenser of claim 42, wherein thehousing houses a dispensing container which contains the fluid productand has a dispensing member, wherein the nozzle has an outlet passagewaythrough which, in use, the fluid product is dispensed from thedispenser, and wherein the container is positioned in the housing sothat the dispensing member and the outlet passageway are in direct fluidcommunication.
 44. The dispenser of claim 43, wherein the dispensingmember is engaged with the outlet passageway.
 45. The dispenser of claim42, wherein the fastening mechanism has a clamp member which clamps thenozzle in the opening.
 46. The dispenser of claim 42, wherein the nozzlehas a flnge abutting an inner surface of the housing and the fasteningmechanism fastens the flange to the inner surface to retain the nozzlein the opening.
 47. The dispenser of claim 45, wherein the clamp memberis a collar structure provided on the inner surface of the housing, thecollar structure being bent or folded over the flange to clamp theflange to the inner surface.
 48. A set of component parts formanufacturing a plurality of fluid dispensers for dispensing a fluidproduct into a nasal cavity of a suer, the set comprising a plurality ofnozzles sized and shaped for insertion into a user's nostril and aplurality of housings for receiving a supply of the fluid product,wherein each nozzle is identical, each housing has an opening forreceiving one of the nozzles, and each housing further has a differentcharacteristic from the others.
 49. The set of claim 48, wherein eachhousing is of a different color.
 50. The set of claim 48, wherein eachhousing is of a different shape.
 51. The set of claim 48, furthercomprising a plurality of containers, one for each dispenser, eachcontainer containing an identical or different fluid medicamentformulation.
 52. A fluid dispenser adapted for dispensing a fluidproduct into the nasal cavity of a user having a nozzle sized and shapedfor insertion into a nostril of the user and a housing in which thefluid product is containable and which has an opening in which thenozzle is receivable, wherein the nozzle is made from a differentmaterial than the housing.
 53. The dispenser of claim 52, wherein thenozzle and the housing are of different plastics materials.